Sinusitis is the most frequently reported chronic disease in the United States, affecting more than 14% of the population. Sinusitis is an inflammation of the mucosa of the paranasal sinuses. Generally, there is an allergic cause to sinusitis. Otitis media, like sinusitis, is also generally considered to have an allergic cause. These are also characterized by retention of thickened respiratory secretions; however, the inflammation is manifest in the ear rather than in the sinuses. A discussion of sinusitis and otitis media can be found in Conn's Current Therapy, 235 (1997); Diseases of the Sinuses--A Comprehensive Textbook of Diagnosis and Treatment, ed. M. E. Gershwin et al, Human Press, Totowa, N.J., pages 151-157 (1996); and Allergy--Principles and Practice, Volume II, ed. E. Middleton, Jr. et al, Mosby-Year Book, Inc., New York, pages 1027-1033 (1998). Also, a review of sinusitis and related facts is given by Z. Pelikan, "The Role of Allergy in Sinus Disease", Clinical Reviews in Allergy and Immunology, 16, 55-156 (1998).
Sinusitis and otitis media are often typically treated as infectious diseases. The treatment typically includes administration of an antibiotic along with a corticosteroid and an antihistamine, or a nasal decongestant. such as described in, for example, J. Braun et al, Allergy, 52 (6) 650-655 (1997). There are, however, occasions, when the sinusitis or otitis media is not necessarily accompanied by an infection. This is particularly true when the disease is associated with allergic rhinitis. At those times, administration of an antibiotic may not be needed. Physicians, however, do not generally administer corticosteroids for these indications without accompanying antibiotic.
Certain corticosteroids, e.g., beclomethasone dipropionate, are commercially available for the treatment of diseases such as rhinitis and bronchial asthma. However, the art does not teach the utility of a corticosteroid as substantially a main component in the treatment of non-infective sinusitis or otitis media in the absence of antibiotics.
It would be desirable to find methods of treatment for non-infective sinusitis or otitis media using an effective amount of substantially a corticosteroid as an active ingredient in the absence of antibiotics.
It would also be desirable to find a corticosteroid which is therapeutically effective in treating sinusitis and otitis media and which also exhibits low bioavailability and low systemic side-effects when it is administered intra-nasally or by oral inhalation.
Other desires, objectives and advantages of the present invention will be apparent to those skilled in the art from the accompanying description and claims.